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New Drug for Male Impotence Backed by FDA Experts

By
Ori TwerskyWebMD Health News

WebMD News Archive

April 10, 2000 (Washington) -- If Viagra fails to do the trick, you may soon
be able to try Uprima, a proposed new treatment for erectile dysfunction. That
is because a committee of experts recommended Monday that the FDA proceed with
Uprima's approval. The final decision will be made sometime in July.

Placed under the tongue, Uprima is a medication that encourages erections by
stimulating the area of the brain responsible for sexual arousal. Although
Uprima is new, its active ingredient, apomorphine, has been used for various
disorders since 1869. For the last half of the 20th century, it has been used
as a sedative, and since 1967, as a treatment for Parkinson's disease.

In medical studies, almost 60% of men taking Uprima had an erection, whereas
only 35% of men taking a placebo were able to successfully achieve an
erection.

But the major area of concern with regard to Uprima was its safety profile,
not its effectiveness. Nausea was seen in 32% of the men, with dizziness and
sweating occurring in about 15%. In the studies, 60% of the men had to drop out
due to side effects. But most of these occurred in men taking at least 5 mg of
the drug. If approved, Uprima will be sold in doses of 2 mg to 4 mg.

Uprima also appeared to interact with nitrates, the common heart drug that
is forbidden in men taking Viagra, and alcohol, leading to concerns about the
potential for more serious side effects, such as passing out, dangerously low
blood pressure, and slow heart rate.

Panel members agreed. But despite the drug's interaction with alcohol and
nitrates, the committee noted that its benefits still outweighed the risks,
eventually voting 9-3 in support of approval. "[Erectile dysfunction] is a
major quality-of-life issue," committee chair Ricardo Azziz, MD, MPH, tells
WebMD. Although this drug may need to be used only in certain men, there is no
question that it had a definite benefit, he says.